Clinical Study of Utidelone Injection in Patients With Advanced or Metastatic Solid Tumors
Status:
Recruiting
Trial end date:
2022-06-01
Target enrollment:
Participant gender:
Summary
This trial is an open, two-stage, multi-center, phase II clinical trial to evaluate the
efficacy and safety of Utidelone in advanced solid tumors (excluding breast cancer, lung
cancer, and colorectal cancer) that have failed standard of treatment or were unable to
perform standard treatment.
This trial is divided into 2 stages, screening stage and expansion stage. In the screening
stage, 10 patients were enrolled for each tumor type(including Squamous cell carcinoma of
head and neck, Esophageal cancer, Stomach cancer, Pancreatic cancer, Cholangiocarcinoma,
Ovarian cancer and Other solid tumors). Based on the results of the tumor type screening
stage, the sponsor and the main investigator will have a discussion and have the alignment of
tumor types to enter the expansion stage. The expansion stage will refine the inclusion /
exclusion criteria and may adjust the treatment plan based on the tumor type and the
combination drug selection. A total of 30-50 patients (including patients enrolled in the
screening stage) were enrolled in each specified tumor type during the expansion stage.